For patients having chronic or acute nutritional needs, percutaneous enteral feeding through a surgically formed ostomy, such as a gastrostomy is often indicated. The gastrostomy is typically formed through use of a percutaneous endoscopic technique and intubated with a gastrostomy tube to effect enteral feeding. U.S. Pat. Nos. 4,795,430 and 4,900,306 are examples of percutaneous endoscopic gastrostomy tubes using an inflatable cuff as a means of anchoring the tube within the gastrostomy.
After initial formation and intubation of the gastrostomy, it is often necessary to replace the gastrostomy tube with a device more suitable to long term feeding needs. These devices characteristically have a low structural profile to be carried closely to the abdominal wall of the patient without discomfort or snagging of clothing. When not in use for enteral feeding, a closure is provided to seal the feeding tube.
An example of one such prior art gastrostomy device is seen in FIGS. 1 and 1A. The prior art device of FIGS. 1 and 1A utilizes a deformable retention pod A which joins an enteral feeding tube B to a retention disk C. Retention pod A is provided with feeding ports D for access into fluid lumen E. To prevent reflux of gastric contents into fluid lumen E, a one-way flapper valve F is provided within pod A. When not being used during enteral feeding, plug G which is carried on retention disk C is inserted into the fluid lumen E.
FIGS. 1 and 1A also disclose a method of intubating a prior art gastrostomy device. An obturator or stylet H is inserted through the fluid lumen and seats within pod A. As the pod passes through the stoma of the gastrostomy, the pod is deformed by the inner walls of the stoma until passing into the stomach at which point the pod assumes an operative configuration. There are many problems associated with the prior art gastrostomy device as disclosed in FIGS. 1 and 1A and other similar devices.
One such problem is that during intubation, the obturator or stylet damages the anti-reflux flapper valve by deforming the valve hinge. As a result, the valve does not fully return to a tightly closed position permitting reflux of gastric contents into the fluid lumen with possible leakage outside of the patient. In addition, a flapper valve limits full utilization of the fluid lumen, thereby restricting fluid flow and impeding accurate fluid infusion. Likewise, the prior art gastrostomy device of FIGS. 1 and 1A also limits fluid effusion by the use of feeding ports D in pod A. These ports inherently restrict effusion of nutritional fluid from the fluid lumen by requiring some fluid to initially backfill the pod before fluid can effuse through the ports. Finally, intubation is made more difficult as the outer configuration and outer dimensions of deformable pod A do not reduce sufficiently to facilitate an easy and a traumatic intubation.
Hence, prior to the development of the present invention, a need existed for a gastrostomy feeding device which addresses these and problems associated with prior art devices.